URIT-12 HAEMOGLOBIN METER

Technical Specifications of  Hemoglobin  meter

Parameter: Hemoglobin in fresh whole blood
Measuring Principle: Optical reflectance
Strip: H12 Hemoglobin Test Strips
Measuring time: Less than 30 seconds
Measuring range: 4.0g/dL ~ 24.0g/dL. Results under 4.0g/dL and over 24.0g/dL will display as “Lo” and “Hi” respectively so as to indicate the result which is out of range.
Display: LCD, test result displaying in SI
Weight: < 58g (Battery included)
Outer dimension: 102mm×50mm×19mm
Power: DC 6V (Two CR2032 Battery)
Operating Ranges: 15 ~ 30°C; RH ≤80% non-condensing
Ultimate Ranges: -20 ~55°C ; RH < 90% non-condensing
Others: Internal trouble check and display
Available life: 8 years

  USE of  Hemoglobin  stripe

[OPERATING INSTRUCTIONS]

·Before doing any test, please refer to the Operator Manual for detailed instructions.

1. Requirement:

URIT-12 Hemoglobin Meter, H12 Hemoglobin Test Strip, blood collection pen, new one-off disinfected blood collection needle.

2. Test steps:

1) Turn the meter on and input the Lot Code. Check the Lot Code displaying on the meter to ensure it to match the Lot Code printed on the test strip container. Otherwise, the result is incorrect.
2) Massage the patient's finger from the knuckle up to the tip to stimulate blood flow. Clean the sample area with alcohol and wipe it dry with a sterile gauze pad.
3) Insert the test strip into the strip holder with the notched end in first and the hole facing up.
4) Pierce the underside of the fingertip by needle, let the blood flow naturally. When a blood symbol displays, apply a drop of blood to the strip spot quickly, and ensure the spot is covered by sufficient blood completely. Blood sample volume should be 13 - 15μL.
5) The meter starts the test automatically after the blood sample disperses. Once the test is in process, do not disturb or move the meter or test strip, or press any key. The test result will display within 30 seconds.

·Notice:
1. Check the expiry date of test strip before test, do not use the test strip after expiry date.
2. A specific Lot Code is assigned to each lot of H12 Hemoglobin Test Strip. Check the Lot Code displaying on the meter to ensure it match the Lot Code printed on the test strip container. For the URIT-12 Hemoglobin Meters which supporting the code card (the only way to enter the Lot code of the test strips for these meters), please refer to URIT-12 Hemoglobin Meter Operating Manual, insert the code card to input the lot code for the test strips.

[OPERATION PRINCIPLE]

The test strip utilizes Dry Chemistry Colorimeter Method (Azido methaemoglobin Method). When a drop of whole blood is applied to the test spot on the strip, blood immediately disperses within the membrane, contacting the reagent. The meter's optical detectors automatically measure the change in membrane reflectance. The intensity of reflectance is inversely proportional to the hemoglobin concentration.

[MEASURING RANGE]

The measuring range of test strip is from 4.0g/dL to 24.0g/dL. Results under 4.0g/dL and over 24.0g/dL will display as“Lo” and “Hi” respectively so as to indicate that the result is out of range.
[NORMAL RANGE OF REFERENCE VALUES]
Adult males: 13.5g/dL–– 18.0g/dL
Adult females: 12.0g/dL–– 16.0g/dL
Infants: from 14.5g/dL–– 22.5g/dL after birth to 11.1g/dL–– 14.1g/dL 6 months old.
Children: gradual change from infant to adult levels.
* Each clinical site should establish its own reference ranges.

[NOTICE]

1. Same as all diagnostic tests, hemoglobin test results should be evaluated with the specific patient's condition. Any results demonstrating the inconsistency with the patient's clinical status should be repeated or supplemented with additional test data.
2. Do not touch the test membrane by hand.
3. H12 Hemoglobin Test Strips are one-off product, do not use again.

[PRECAUTIONS]

1. The suitable operation temperature range of H12 Hemoglobin Test Strip is 15°C to 30°C. Do not expose it to the extreme temperature, as such exposure could affect result.
2. Blood plasma and serum should not be used in this system. No result will be obtained from testing with arterial blood.
3. Insufficient blood sample will affect the result. Hereby, check whether the reverse of strip spot is dyed completely or not. If the splash is incomplete, it means the blood is insufficient, do not accept this result.
4. Other than EDTA are not recommended for use, such as sodium citrate and heparin.
5. High bilirubin, cholesterol, triglycerides or others may interfere the test.

[SPECIFICATION] 25 pieces

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